A 16 Weeks Study on Efficacy and Safety of Two Doses of Empagliflozin (BI 10773) (Once Daily Versus Twice Daily) in Patients With Type 2 Diabetes Mellitus and Preexisting Metformin Therapy

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01649297
First received: July 23, 2012
Last updated: March 27, 2014
Last verified: March 2014

July 23, 2012
March 27, 2014
October 2012
December 2013   (final data collection date for primary outcome measure)
Change in glycated hemoglobin from baseline [ Time Frame: Baseline and 16 weeks ] [ Designated as safety issue: No ]
Change in glycated hemoglobin from baseline [ Time Frame: week 1 and week 16 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01649297 on ClinicalTrials.gov Archive Site
Change in fasting plasma glucose from baseline [ Time Frame: Baseline and 16 weeks ] [ Designated as safety issue: No ]
  • Change in fasting plasma glucose from baseline [ Time Frame: week 1 and week 16 ] [ Designated as safety issue: No ]
  • Change in fasting plasma glucose by visit over time [ Time Frame: up to 16 weeks ] [ Designated as safety issue: No ]
  • Change in glycated hemoglobin by visit over time [ Time Frame: up to 16 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A 16 Weeks Study on Efficacy and Safety of Two Doses of Empagliflozin (BI 10773) (Once Daily Versus Twice Daily) in Patients With Type 2 Diabetes Mellitus and Preexisting Metformin Therapy
A Randomised, Double Blind, Placebo Controlled, Parallel Group Efficacy and Safety Study of Oral Administration of Empagliflozin Twice Daily Versus Once Daily in Two Different Daily Doses Over 16 Weeks as add-on Therapy to a Twice Daily Dosing Regimen of Metformin in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control

The aim of this study is to investigate the efficacy and safety of two doses (high and low) of empagliflozin as add-on therapy to metformin in patients with type 2 diabetes mellitus (T2DM) and insufficient glycaemic control. Both doses may be given once daily or split to a twice daily dosage. This results in 4 different dosage regimens of empagliflozin (high dose once daily or split vs. low dose once daily or split). This is done to evaluate whether a twice daily dose regimen of empagliflozin results in a loss of efficacy relative to once daily dosing when given on top of metformin background therapy.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: Placebo
    Patients receive placebo matching empagliflozin (low dose qd)
  • Drug: Placebo
    Patients receive placebo matching empagliflozin (low dose bid)
  • Drug: Placebo
    Patients receive placebo matching Empagliflozin (high dose qd)
  • Drug: empagliflozin (low dose qd)
    Patients receive Empagliflozin low dose once daily
  • Drug: Placebo
    Patients receive placebo matching Empagliflozin (high dose bid)
  • Drug: Empagliflozin (high dose qd)
    Patients receive Empagliflozin high dose once daily
  • Drug: empagliflozin (high dose bid)
    Patients receive Empagliflozin high dose split twice daily
  • Drug: empagliflozin (low dose bid)
    Patients receive Empagliflozin low dose split twice daily
  • Experimental: empagliflozin (high dose qd)
    Patients receive Empagliflozin high dose once daily
    Interventions:
    • Drug: Placebo
    • Drug: Placebo
    • Drug: Placebo
    • Drug: Empagliflozin (high dose qd)
  • Experimental: empagliflozin (high dose bid)
    Patients receive Empagliflozin high dose split twice daily
    Interventions:
    • Drug: Placebo
    • Drug: Placebo
    • Drug: Placebo
    • Drug: empagliflozin (high dose bid)
  • Experimental: empagliflozin (low dose qd)
    Patients receive Empagliflozin low dose once daily
    Interventions:
    • Drug: empagliflozin (low dose qd)
    • Drug: Placebo
    • Drug: Placebo
    • Drug: Placebo
  • Experimental: empagliflozin (low dose bid)
    Patients receive Empagliflozin low dose split twice daily
    Interventions:
    • Drug: Placebo
    • Drug: Placebo
    • Drug: Placebo
    • Drug: empagliflozin (low dose bid)
  • Placebo Comparator: Placebo
    Patients receive placebo matching Empagliflozin
    Interventions:
    • Drug: Placebo
    • Drug: Placebo
    • Drug: Placebo
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
983
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion criteria:

  1. confirmed diagnosis of T2DM
  2. Glycated hemoglobin (HbA1c) >=7.0 and <=10/0% at Visit 1
  3. Metformin therapy (at least 1500 mg/day, BID)
  4. age>=18 at Visit 1
  5. body mass index <=45 kg/m2

Exclusion criteria:

  1. estimated creatinine clearance rate (eCCr) <60 ml/min (Cockcroft-Gault formula) screening and/or run-in
  2. a confirmed glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   Estonia,   France,   Georgia,   Germany,   Guatemala,   Italy,   Latvia,   Lithuania,   Mexico,   New Zealand,   Poland,   Russian Federation,   South Africa,   Spain,   Ukraine
 
NCT01649297
1276.10, 2012-000905-53
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Eli Lilly and Company
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP